SIEMEMNS INFINITY ETC02 POD

K992116 · Siemens Medical Solutions USA, Inc. · CCK · Jan 12, 2000 · Anesthesiology

Device Facts

• Record ID: K992116
• Device Name: SIEMEMNS INFINITY ETC02 POD
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Jan 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The intended use of Siemens INFINITY etCO2 pod is to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in both mainstream and side-stream measurement modes (side-stream is not intended for use in the neonatal population). In conjunction with an INFINITY modular bedside monitor, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.

Device Story

INFINITY etCO2 Pod is a modular bedside monitoring accessory for Siemens SC7000/SC8000/SC9000XL series; measures end-tidal CO2, inspired CO2, and respiration rate via mainstream or side-stream sampling. Uses dual-wavelength, non-dispersive infrared (NDIR) technology to analyze gas samples; connects to modular monitors for data processing. Provides real-time CO2 values and respiration rates; triggers visual/audible alarms when parameters exceed preset limits; generates timed or alarm-based recordings. Operated by healthcare professionals in clinical environments. Output allows clinicians to monitor patient respiratory status and ventilation adequacy; aids in clinical decision-making regarding patient respiratory support.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Dual-wavelength, non-dispersive infrared (NDIR) gas analyzer. Measures CO2 partial pressure (0-100 mmHg). Supports mainstream and side-stream sampling. Connectivity via Siemens INFINITY modular bedside monitor interface. Standards: EN 864:1996, IEC 60601-1. Form factor: modular pod.

Indications for Use

Indicated for adult, pediatric, and neonatal populations (side-stream mode contraindicated for neonates) in healthcare settings by physicians, nurses, or technicians to measure end-tidal CO2, inspired CO2, and respiration rate. Not for use in MRI magnetic fields.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• Siemens SC9000 etCO2 Module (K954632)
• Novametrix CO2SMO Plus (K963380)

Submission Summary (Full Text)

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### 510(k) SUMMARY

as required per 807.92(c)

## 1. Submitters Name, Address:

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: June 11, 1999

#### Trade Name, Common Name and Classification Name: 2.

- A. Trade Name: Siemens INFINITY etCO2 Pod
#### Common Name, Classification Name, Class and Regulation Number: B.

| Common Name | Classification<br>Number | Class | Regulation Number |
|----------------------------------------------|--------------------------|-------|-------------------|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 73CCK | II | 868.1400 |

#### Predicate Device Identification: 3.

Siemens SC9000 etCO2 Module 510(k) K954632

Novametrix CO2SMO Plus 510(k) K963380

#### 4. Device Description:

The INFINITY etCO2 Pod is an addition to Siemens SC8000/SC7000/SC9000XL INFINITY modular bedside monitoring series. When connected to an INFINITY modular bedside monitor the etCO2 pod will measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate.

#### ડ. Intended Use:

The intended use of Siemens INFINITY etCO2 pod is to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in both mainstream and side-stream measurement modes (side-stream is not intended for use in the neonatal population). In conjunction with an INFINITY modular bedside monitor, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.

### -

### COMPANY CONFIDENTIAL

### Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

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## 6. Table of Device Similarities and differences to predicate device

| Predicate Device | Predicate Device | Applicant | Explanation of<br>Differences | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Manufacturer | Siemens Medical Systems<br>SC9000 etCO2 Module | Novametrix Medical Systems<br>CO2SMO Plus | Siemens Medical Systems<br>INFINITY etCO2 Pod | |
| 510(k) Number | K954632 | K963380 | To be assigned | |
| Intended Use | To measure end tidal carbon dioxide,<br>inspired carbon dioxide, and<br>respiration rate in both mainstream<br>and side-stream measurement modes<br>(side-stream is not intended for use in<br>the neonatal population). In<br>conjunction with the SC9000, visual<br>and audible alarms will be produced<br>if any of these parameters vary<br>beyond preset limits, and timed or<br>alarm recordings will be produced. | To provide spirometric, carbon<br>dioxide and pulse oximetry<br>monitoring | To measure end tidal carbon dioxide,<br>inspired carbon dioxide, and respiration rate<br>in both mainstream and side-stream<br>measurement modes (side-stream is not<br>intended for use in the neonatal<br>population). In conjunction with the SC<br>7000 / SC 8000 / SC 9000XL monitors,<br>visual and audible alarms will be produced<br>if any of these parameters vary beyond<br>preset limits, and timed or alarm recordings<br>will be produced. | Siemens etCO2 pod does<br>not measure or display<br>spirometry or pulse<br>oximetry |
| Intended Population | Adult/Pediatric | Adult/Pediatric/Neonatal | Adult/Pediatric/Neonatal | |
| Intended<br>Environment | A healthcare environment by<br>healthcare professionals | Same | Same | |
| Measuring Capabilities | | | | |
| Displayed parameters | EtCO2, iCO2, Respiration rate (RRc) | Spirometry, Pulse oximetry,<br>EtCO2, iCO2, Respiration rate<br>(RRc) | EtCO2, iCO2, Respiration rate (RRc) | Siemens etCO2 pod does<br>not measure or display<br>spirometry or pulse<br>oximetry |
| Display Scales | 0-40, 0-80 mmHg | 0-50, 0-75, 0-100 mmHg | 0-40, 0-60, 0-80, 0-100 mmHg | More display flexibility |
| Measuring method | Dual-wavelength, non-dispersive<br>infrared | Same | Same | |
| Measuring<br>capabilities | Mainstream and Sidestream | Same | Same | |
| Measuring range | 0 to 99 mmHg CO2 partial pressure | 0 to 100 mmHg partial pressure | 0 to 100 mmHg CO2 partial pressure | *A CO2 ≥ 100 is<br>considered out of range |
| Averaging | Breath, 10s, 20s | Breath, 10s, 20s, Instantaneous | Breath, 10s, 20s, Instantaneous | Improvement |

2

## COMPANY CONFIDENTIAL

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7. Assessment of non-clinical performance data for equivalence: Section T

- 8. Assessment of clinical performance data for equivalence: Section V
- 9. Biocompatability: Not applicable
- 10. Sterilization: Not applicable
- 11. Standards and Guidances: EN 864: 1996 IEC 60601-1

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## COMPANY CONFIDENTIAL

# Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: [phone] Fax: [phone] Telex: 511958 (Siemensm SD)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2000

Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

Re: K992116 Siemens INFINITY etCO2 Pod Regulatory Class: II (two) Product Code: 73 CCK October 15, 1999 Dated: Received: October 15, 1999

Dear Mr. Simard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David Simard

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

feamothw. Wutoduca fro,

elia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): _

Device Name: Siemens INFINITY etCO2 Pod

Indications for Use:

Siemens INFINITY etCO2 is indicated for use in the adult, pediatric and neonatal populations, in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode is not intended for use in the neonatal patient population). In conjunction with the SC 7000 / SC 9000XL monitors, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.

MRI Compatibility Statement: The Siemens INFINITY etCO2 Pod is not intended for use in a MRI magnetic field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

to AW. Watscher

Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K9921116